Quality Audit & Compliance Specialist — Inspections

VARITE INC; Greenville (NC); Vor Ort; USD 58.000 - 62.000; Vollzeit

Benefits dieser Stelle

Health Insurance

Retirement Plans

Legal Service Plans

Zusammenfassung

VARITE INC is seeking a Quality Specialist III in Greenville, NC for a 12-month onsite role. The position focuses on audits, inspections, and regulatory compliance under 21 CFR and related standards.

You will coordinate external client audits, readiness activities, and CAPA governance within a fast-paced life science environment. Requirements include a Bachelor's in a scientific/engineering/health field and 5+ years in pharma/medical device quality, with 8 years in related quality roles.

Qualifikationen

• Bachelor's degree in a scientific, engineering, or health-related field.
• At least 5 years of experience in pharmaceutical or medical device industry.
• At least 8 years of quality experience in deviation management, pharmaceutical operations, quality assurance, or related areas within pharma/healthcare.

Aufgaben

• External Audit Preparation & Execution: support scheduling, hosting, and responding to external client audits.
• Inspection Readiness & Execution: support mock inspections and actual regulatory inspections with agencies such as FDA, EMA, ANVISA, MHRA.
• Governance (Metrics & Monitoring): track, trend, and analyze audit/inspection data to identify risks and drive improvement; report KPIs to leadership.
• Deviation & CAPA Management: monitor deviations and CAPAs; ensure timely responses and actions.
• Effectiveness Checks: define and validate effectiveness for audit CAPAs to prevent recurrence.
• Communications: use effective channels to ensure awareness and participation in audits and inspections.
• Documentation & Record retention: ensure critical documents are stored to support audits and inspections.

Kenntnisse

CFR Part 210/211

CFR Part 600

QMSR

ISO 13485

ISO 9001

ICH Q9 Q10

Communication

Cross-functional

Problem solving

TrackWise familiarity

Documentum familiarity

Veeva Vault familiarity

Ausbildung

Bachelor's degree in science/engineering/health

Tools

Documentum

Veeva Vault

TrackWise

Jobbeschreibung

VARITE INC is seeking a Quality Specialist III in Greenville, NC for a 12-month onsite role. The position focuses on audits, inspections, and regulatory compliance under 21 CFR and related standards.

You will coordinate external client audits, readiness activities, and CAPA governance within a fast-paced life science environment. Requirements include a Bachelor's in a scientific/engineering/health field and 5+ years in pharma/medical device quality, with 8 years in related quality roles.